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AboutPricing
Drug ReportsElagolix
Elagolix
Oriahnn, Orilissa (elagolix) is a small molecule pharmaceutical. Elagolix was first approved as Orilissa on 2018-07-23. It is used to treat abdominal pain in the USA. The pharmaceutical is active against gonadotropin-releasing hormone receptor.
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EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Orilissa
Combinations
Oriahnn
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Elagolix sodium
+
Elagolix sodium
+
Estradiol
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
ORIAHNN (COPACKAGED)AbbVieN-213388 RX2020-05-29
1 products, RLD, RS
Elagolix sodium
Tradename
Company
Number
Date
Products
ORILISSAAbbVieN-210450 RX2018-07-23
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
oriahnnNew Drug Application2023-06-05
orilissaNew Drug Application2023-06-05
orlissaNew Drug Application2018-07-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
primary ovarian insufficiencyEFO_0004266D016649E28.3
abdominal painEFO_0003766D015746R10.9
hot flashes—D019584—
hypogonadism—D007006E23.0
premature menopause—D008594E28.31
Agency Specific
FDA
EMA
Expiration
Code
ELAGOLIX SODIUM, ORILISSA, ABBVIE
2023-07-23NCE
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE / ELAGOLIX SODIUM, ORIAHNN (COPACKAGED), ABBVIE
2023-07-23NCE
2023-05-29NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Elagolix Sodium, Orilissa, Abbvie
115422392039-07-23DS, DP
105375722036-09-01U-2735
106823512036-09-01U-2850
113445512034-03-14U-3388, U-3389
70569272024-09-10DS, DP
71762112024-07-06U-2360
74199832024-07-06DS, DPU-2360
Elagolix Sodium,Estradiol,Norethindrone Acetate / Elagolix Sodium, Oriahnn (Copackaged), Abbvie
108816592034-03-14U-2842
110454702034-03-14U-2842
114593052028-11-07DPU-2842
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01C: Hypothalamic hormones
— H01CC: Anti-gonadotropin-releasing hormones
— H01CC03: Elagolix
HCPCS
No data
Clinical
Clinical Trials
39 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeiomyomaD007889—D25—241411
MenorrhagiaD008595EFO_0003945N92.0—241310
HemorrhageD006470MP_0001914R58—24118
MyofibromaD047708———24118
AnovulationD000858—————1—1
Cerebrovascular disordersD002561EFO_0003763I60-I69———1—1
AgingD000375GO_0007568R41.81———1—1
MenopauseD008593EFO_0003922N95———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EndometriosisD004715EFO_0001065N802711—323
InfertilityD007246EFO_0000545—112——4
DysmenorrheaD004412—N94.6——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Uterine hemorrhageD014592———2———2
Polycystic ovary syndromeD011085EFO_0000660E28.2—1———1
SyndromeD013577———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I981————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameElagolix
INNelagolix
Description
Elagolix is an organooxygen compound and an organonitrogen compound. It is functionally related to a gamma-amino acid.
Classification
Small molecule
Drug classgonadotropin releasing hormone (GnRH) receptor antagonists (nonpeptide)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Identifiers
PDB—
CAS-ID834153-87-6
RxCUI—
ChEMBL IDCHEMBL1208155
ChEBI ID—
PubChem CID11250647
DrugBankDB11979
UNII ID5B2546MB5Z (ChemIDplus, GSRS)
Target
Agency Approved
GNRHR
GNRHR
Organism
Homo sapiens
Gene name
GNRHR
Gene synonyms
GRHR
NCBI Gene ID
2798
Protein name
gonadotropin-releasing hormone receptor
Protein synonyms
gnRH receptor, gnRH-R, gonadotropin-releasing hormone (type 1) receptor 1, leutinizing hormone releasing horomone receptor, leutinizing-releasing hormone receptor, luliberin receptor, type I GnRH receptor
Uniprot ID
Q92644
Mouse ortholog
Gnrhr (14715)
gonadotropin-releasing hormone receptor (Q61611)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Oriahnn – AbbVie
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 510 documents
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Safety
Black-box Warning
Black-box warning for: Oriahnn
Adverse Events
Top Adverse Reactions
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4,196 adverse events reported
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